Gallbladder Removal Clinical Trials

Clinical trials related to Gallbladder Removal Procedure

Comparison of M-TAPA and External Oblique Intercostal Plane Block on Intraoperative Analgesia and Opioid Consumption Guided by Skin Conductance Algesimeter in Laparoscopic Cholecystectomy

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This prospective observational study is designed to evaluate the effects of modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) and external oblique intercostal (EOI) plane block on intraoperative analgesia and opioid consumption in patients undergoing elective laparoscopic cholecystectomy. Abdominal wall blocks are widely used to improve perioperative analgesia; however, their impact on intraoperative opioid requirements when guided by objective nociception monitoring remains unclear. All patients will receive standardized general anesthesia. Intraoperative analgesia will be guided using the Skin Conductance Algesimeter (SCA), which reflects sympathetic nervous system activity by measuring fluctuations in skin conductance. The SCA parameter peaks per second (PPS) will be used to assess nociceptive responses. Remifentanil infusion will be titrated according to SCA values to maintain adequate analgesia. Dose adjustments will be performed at predefined intervals, and changes will be considered valid only if sustained for a minimum duration. Patients will receive either M-TAPA or EOI block as part of routine clinical practice. The choice of block will not be influenced by the investigators, in accordance with the observational design of the study. Data will be collected prospectively during the intraoperative period and postoperative follow-up. The primary outcome of the study is the time-weighted average intraoperative remifentanil infusion rate (µg/kg/min). Secondary outcomes include total intraoperative remifentanil consumption (µg/kg), intraoperative hemodynamic parameters (heart rate and mean arterial pressure), frequency of deviations in SCA values from the target range, postoperative pain scores assessed using a numeric rating scale (NRS), time to first analgesic requirement, and total rescue analgesic consumption. Perioperative analgesia will be standardized. All patients will receive intravenous dexketoprofen toward the end of surgery as part of routine clinical practice. Rescue analgesia will be provided with intravenous dexketoprofen when clinically indicated. Additional outcomes include postoperative nausea and vomiting and perioperative complications. This study aims to provide objective data on the opioid-sparing effects of different abdominal wall block techniques when intraoperative analgesia is guided by nociception monitoring. The findings may contribute to optimizing analgesic strategies and improving perioperative pain management in laparoscopic surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Patients aged 18-80 years

• ASA physical status I-III

• Scheduled for elective laparoscopic cholecystectomy under general anesthesia

• Ability to provide written informed consent

Locations
Other Locations
Turkey
Ankara etlik city hospital
RECRUITING
Ankara
Contact Information
Primary
İsmet Uluhan, MD
ismtptlk@gmail.com
+905077128389
Time Frame
Start Date: 2026-05-15
Estimated Completion Date: 2026-09
Participants
Target number of participants: 80
Treatments
M-TAPA Group
Patients receiving ePatients receiving modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) for intraoperative analgesia during laparoscopic cholecystectomy.ternal oblique intercostal plane block (EOI) for analgesia
EOI Group
Patients receiving external oblique intercostal plane (EOI) block for intraoperative analgesia during laparoscopic cholecystectomy.
Sponsors
Leads: Ankara Etlik City Hospital

This content was sourced from clinicaltrials.gov